Isomedix Operations, Inc.

FDA Device Registration & Listing · Libertyville, IL, US · Registration 1424263

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1424263
FEI Number
3003015552
Entity Name
Isomedix Operations, Inc.
City/State/Country
Libertyville, IL, US
Establishment Address
2500 Commerce Dr, Libertyville, IL 60048, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERIS Corporation (Owner Number: 1527821)
Owner / Operator Contact Address
5960 Heisley Rd, --, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OmegaSurgical (LSRTC) - BUR, SURGICAL, GENERAL & PLASTIC SURGERY BioAccess1719 (WH) - Collet BioAccess1719 (WH) - Keyless Chuck BioAccess1719 (WH) - Wire Chuck BioAccess1719 (WH) - NGD-1000 BioAccess1719 (WH) - Small Bone Tool BioAccess1719 (WH) - NGD-1005A BioAccess1719 (WH) - Quick Release BioAccess1719 (WH) - Tool with Chuck BioAccess1719 (WH) - Small Bone Tool with Collet BioAccess1719 (WH) - High Torque Tool BioAccess1719 (WH) - WF-100 Zimmer (LN,LS) - COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE Zimmer (LS) - Affixus Tibial Nailing System - 4mm screws Accumedix3772 (LS) - Blue Sky Bio TAD Medivis37554 (LSRTC) - Cranial Navigation System Zimmer (LN,LS) - G7 Acetabular System Zimmer (LN,LS) - Comprehensive® Reverse Shoulder Zimmer (LN,LS) - COMPREHENSIVE REVERSE SHOULDER SCREWS Accumedix3772 (LS) - Blue Sky Bio Dental Implant System - Octagon Regular and Wide Short Anodyne3068 (LN, LS) - CRAWFORD-CATLANO INTUBATION Atrium1623 (NR) - Chest Drain Accessories Ursel11054 (MN) - Thora-Vent Thoracic Vent PFMMedical6614 (TM) - Asept; Jet-Vac Zimmer (LN,LS) - SMALL BONE LOCKING PLATING SYSTEM Zimmer (LN,LS) - DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE Accumedix3772 (LS) - Blue Sky Bio Pterygoid Implants and Abutments Zimmer (LN,LS) - COCR MODULAR HEADS - PRIMARY Zimmer (LN,LS) - ZIMMER BIOMET TYPE1 COCR HEADS MoldedProducts4803 (LS) - Collection Assist Device Zimmer (LN,LS) - Echo Bi-Metric Microplasty Hip System Zimmer (LN,LS) - StageOne Select Hip Cement Spacer Molds MoldedProducts4803 (LS) -Luer to Luer Adapter,Sterile DIN Adapter- Polypropylene,Sterile Dead End Female Hansen Connecto StrykerPR3324 (GR, LS, VG) - 10 G Bone Biopsy kit StrykerPR3324 (GR, LS, VG) - iVAS Bone Biopsy Kit 10G, 11G, 13G StrykerPR3324 (GR) - 10 G Bone Biopsy kit StrykerPR3324 (GR,VG) - 8 Gauge Biopsy StrykerPR3324 (GR,VG) - 13G Bone Biopsy Kit StrykerPR3324 (GR,VG) - 9" 10G Bone Biopsy Kit StrykerPR3324 (GR, LS, VG) - 11G Bone Biopsy Kit StrykerPR3324 (GR,VG) - 10G Biopsy Kit Zimmer (LN, LS) - Trauma Fixation Systems Robling1585 (SP) - Fibulink Removal Kit MoldedProducts4803 (LS) - Recirculation Loop with Sampling Port Zimmer (LN,LS) - 2.5MM INLINE FUSION PLATE Zimmer (LN,LS) - DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE Hollister (LN, LS) - Hollister Horizontal Tube Attachment Device Atricure2121 (GR,LN*,LS*) - AtriClip PRO-Mini LAA Exclusion System (PROM) SurgicalTech4007 (LS) - FlexiTip, FlexiTip XL, FlexiTip XL-R Zimmer (LN,LS) - Versanail Zimmer (LN,LS) - LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM Zimmer (LN,LS) - DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE Zimmer (LN,LS) - Biomet Headless Compression And Twist-Off Screws Zimmer (LN,LS) - 2.5 MM MULTIDIRECTIONAL THREADED PEGS, 1.5 MM LOCKING SCREWS Zimmer (LN,LS) - DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE Zimmer (LN,LS) - A.L.P.S. CALCANEAL PLATING SYSTEM Atricure2121 (GR,LN*.LS*) - AtriClip FLEX-Mini LAA Exclusion System (ACHM) Merit1383 (TM) - Worley Slitter Merit1383 (TM) - Transavalvular Insertion tool (TVI) Merit1383 (TM) - Contamination Sleeve Protech3048 (TM) - Helix Locking Tool (HLT), Model A001HELX Carefusion (EP1,SN,LS,NT) - Secondary Sets with Shrouded Needle Zimmer (LN,LS) - Comprehensive Shoulder System PFMMedical6614 (TM) - Jet-Vac Drainage Line (Ref M7099) PFMMedical6614 (TM) - ASEPT Replacement Valve (Ref M7004) PFMMedical6614 (TM) - Jet-Vac Large Bore Drainage Line Set (Ref M7098) PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref M7005) PFMMedical6614 (TM) - Jet-Vac Drainage Line Extension (Ref M7097) PFMMedical6614 (TM) - ASEPT Power Flush Adaptor Ursel11054 (MN) - Posi-Stick Introducer Set Prava (LSRTC) - UGARing Merit1383 (TM) - Prelude SNAP 165 Valved Splittable Sheath Introducer WilsonWolf3589 (LS,LN*) - G-Rex® 100M-CS Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 100 Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 10 Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 10M Open System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 6 Well Plate WilsonWolf3589 (LS,LN*) - G-Rex® 6M - 2cm2/Well, 6-Well Cell Culture Plate WilsonWolf3589 (LS,LN*) - G-Rex® 10M-CS Closed System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 24 Well Plate WilsonWolf3589 (LS,LN*) - G-Rex® 100M-CS Closed System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 6M - 5cm2/Well, 6-Well Cell Culture Plate WilsonWolf3589 (LS,LN*) - G-Rex® 5M Open System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 100M Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS Cell Culture Product CorningME1979 (CH1) - Corning Polystyrene Microcarrier beads, Corning Synthemax Microcarrier beads WilsonWolf3589 (LS,LN*) - G-Rex® 500M-TF Tissue Fragment, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 500M, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 6M Well Plate WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS, Closed System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS, Closed System, Research Use Only WilsonWolf3589 (LS,LN*) - G-Rex® 50M-TF Research Use Only Zimmer (LN,LS) - Comprehensive Shoulder System Merit1383 (NT,SN) - StayFIX Fixation Device PFMMedical6614 (TM) - ASEPT Drainage Catheter Dressing Kit (Ref M7041) Ursel11054 (MN) - TRU-FIX Catheter Fixation Kit Insulet5490 (NR) - PodPals Adhesive Overlay Insulet5490 (NR) - Adhesive Overlay Extremity10109 (WH) - KinematX Total Wrist Arthoplasty System Hollister (SP,LS,LN) - Moderma Flex; New Image; Nova 2; NovaLife 1; NovaLife 1 GX+; NovaLife 2; NovaLife 2 GX+; Pouchkin Hollister (LN, LS) - Ostomy Skin Barriers Hollister (SP,LS,LN) - Premier; Restore; Securi-T USA; Suavita; Tandem; Urostomy Drain Tube Adapter Hollister (LN, LS) - Hollister Hollister (SP,LS,LN) - Adapt; Center Point Lock; Compact; Conform 2; Dansac; Drainable Pouch Clamp; DuoSoft; Fecal Colle Hollister (SP,LS,LN) -First Choice; Holligard; Hollister Solo Stoma Cap; Invent; Karaya 5; Moderma Flex; New Image Zimmer (LN,LS) - DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE Zimmer (LN,LS) - PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS Accumedix3772 (LS) - Heathrow Scientific Zimmer (LS) - Creartions SCP Hip Kit StrykerPR3324 (GR,LS, VG) - Strykeflow Single Spike Tube Set StrykerPR3324 (GR, LS, VG) - PKG., STRYKEFLOW SUCTION/IRRIGATOR PS StrykerPR3324 (VG,GR) - StrykeFlow PS StrykerPR3324 (VG,GR) - Strykeflow Single Spike Tube Set Zimmer (LN,LS) - VANGUARD COMPLETE KNEE SYSTEM Zimmer (LN,LS) - Bit, drill StrykerPR3324 (GR, LS, VG) - Twinloop FLEX TM Drill StrykerPR3324 (GR, LS, VG) - TwinLoop FLEX Zimmer (LN,LS) - Cannulated toggle button drill 4.5 MM Zimmer (LN,LS) - Maxfire Zimmer (LN,LS) - Toggleloc Eagle1350 (NT,SN) - Drill OmegaSurgical (LSRTC) - BIT, DRILL OrchidUnique5936 (LN) - Bit, Drill - Omega Zimmer (LN,LS) - ALPS Proximal Humerus Plating System Accumedix3772 (LS) - Blue Sky Bio Dental Implant System - Bio / Conus StrykerPR3324 (GR, LS) - 8 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 6.5mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5mm X 90mm Threaded Cannula StrykerPR3324 (GR, LS, VG) - CANNULA PLUG StrykerPR3324 (GR, LS) - 5 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 6.5mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 8mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 5mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 8mm X 90mm Threaded Cannula StrykerPR3324 (GR, LS) - 5mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 8 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 5 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 8mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 5mm X 90mm Threaded Cannula Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 45mm Threaded Smith&Nephew3754 (NR) - CLEAR-TRAC Disposable Scope/Shaver Cannula, with Distal Rib Smith&Nephew3754 (NR) - Fixation Post, 5mm x 30mm Smith&Nephew3754 (NR) - DISP KNIFE ROSSETTE 3MM STR(5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 7mm x 72mm, Threaded Smith&Nephew3754 (NR) - SUTURE Threaders Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 45mm, Threaded Smith&Nephew3754 (NR) - ACUFEX Clear.Trac Threadedd.10 IDx76 LTX(10) Smith&Nephew3754 (NR) - DISPOSABLE KNIFE V SHAPED Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 35mm Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 8mm LTX Free (10) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 6.5 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 90mm, Threaded Smith&Nephew3754 (NR) - DISPOSABLE KNIFE HOOK 3MM (5) Smith&Nephew3754 (NR) - Split Cannula Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 4.5mm x 72mm, Threaded Smith&Nephew3754 (NR) - CLEAR-TRAC Disposable Scope/Shaver Cannula, Smooth Smith&Nephew3754 (NR) - TRANSPORTER (BOX 4) STERILE Smith&Nephew3754 (NR) - Clear-Trac Thrd Cann 5mm/76mm LTX Free (10) B Smith&Nephew3754 (NR) - Endoscopic Cann.Drill.Bit 4.5mm Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 90mm Threaded Smith&Nephew3754 (NR) - Fixation Post, 5mm x 40mm Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 6.5 x 72mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 7mm x 72mm, Smooth Smith&Nephew3754 (NR) - Univ Cannula 5mm/76mm LTX Free (10) Blue Smith&Nephew3754 (NR) - 3.8mm Tapered Awl, Disposable Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 9mm LTX Free (10) Smith&Nephew3754 (NR) - DISPOSABLE KNIFE SERRATED (5) Smith&Nephew3754 (NR) - PCL Safety Guidewire, 2.4mm x 25cm Smith&Nephew3754 (NR) - Guide Wire, 1.2mm x 12” (Box 5) Smith&Nephew3754 (NR) - Guide Wire, 1.2mm x 9” (Box 5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 4.5 x 72mm Threaded Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 30mm Smith&Nephew3754 (NR) - MENISCUS MENDER II DISPOSABLE Smith&Nephew3754 (NR) - Clear-Trac Complete Hip Cannula Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 5.5mm x 45mm, Threaded Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 7mm LTX Free (10) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 55mm Threaded Smith&Nephew3754 (NR) - DISPOSABLE KNIFE SHARP TIP Smith&Nephew3754 (NR) - Flexible Passing Pin, 13.50” X 2.4mm (Qty 5) Smith&Nephew3754 (NR) - SUTURE PASSER 2 STERILE Smith&Nephew3754 (NR) - Passing Pin, Drill Tip, 2.4mm x 15” Smith&Nephew3754 (NR) - DISP KNIFE SERRATED FLAT(BX 5) Smith&Nephew3754 (NR) - Clear-Trac Threaded Cann 8mm/76mm LTX Free (10) G Smith&Nephew3754 (NR) - (6) Guidewire 2mm x 15 Smith&Nephew3754 (NR) - Univ Cannula 7mm/76mm LTX Free (10) Green Smith&Nephew3754 (NR) - (5) Guidewire, 1.2mmx 18” (46 cm) Smith&Nephew3754 (NR) - Fixation Post, 5mm x 35mm Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 25mm Smith&Nephew3754 (NR) - SUTURE PASSER 12 STERILE Smith&Nephew3754 (NR) BONE TUNNEL PLUG CANN 7-12MM LTX FREE (6 Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 72mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 72mm, Threaded Smith&Nephew3754 (NR) - Fixation Post, 5mm x 25mm Smith&Nephew3754 (NR) - Clear-Trac Complete Stopcock Valve Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 40mm Smith&Nephew3754 (NR) - DISP KNIFE ROUND TIP (BX 5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 55mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 5.5mm x 72mm, Threaded Conmed (SX) - FENESTRATED CANNULA BeInnovative11045 (LN) - Rotolock Cord Management System Hydrofera (NR, WH) - Instrument Wipe SurgicalTech4007 (LS) - FlexiTip, FlexiTip XL, FlexiTip XL-R Etex2142 (NR) - Precision Cannula 150 mm PhoenixMed2991 (SP) - Various Instruments Acuderm1463 (WH,LS) - Acu-Dispo-Ce PhoenixMed2991 (SP) - Instrument, manual, surgical, general use Abyrx4508 (WH) - Abyrx Putty Applicator Protech3048 (TM) - INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Protech3048 (TM) - PHANTOM ML LIGHT CABLE Design2052 (NR) - CTS Relief Kit Zimmer (LN,LS) - JUGGERKNOTLESS SOFT ANCHORS TigerAesthetics14268 (LS) - Lipoaspirate Washing System for Aesthetic Body Contouring Zimmer (LN,LS) - StageOne Knee Cement Spacer Molds MoldedProducts4803 (LS) - Luer to Luer Adapters MoldedProducts4803 (LS) - Luer to Luer Adapter,Luer Lock Cap set MoldedProducts4803 (LS) - Luer to Luer Adapter,Sterile DIN Adapter- Polypropylene MoldeDProducts4803 (LS) - Luer Lock Cap Set,Male to Male Luer Adapter MoldedProducts4803 (LS) - Male to Male Luer Adapter MoldedProducts4803 (LS) - Luer to Luer Adapter,Latex-Free Intermittent Injection Cap-Sterile MoldedProducts4803 (LS) -Luer to Luer Adapter,Sterile DIN Adapter- Polypropylene,Sterile Dead End Female Hansen Connecto Hollister (LN, LS) - HOLLISTER STOMA BAGS; Hollister Wound Drainage Collectors; STOMA BAGS Hollister (LN, LS) - A BAGS; HOLLISTER DRAINING WO; HOLLISTER DRAINING WOUND MANAGEMENT; Hollister (SP) - New Image; Premier; Securi-T USA; Tandem Hollister (SP) -Adapt; Center Point Lock; Compact; Conform 2; Dansac; Drainable Pouch Clamp; DuoSoft; Fecal Collectors; First Choice; Hollister (SP) - Nova 2; NovaLife 1; NovaLife 1 GX+; NovaLife 2; NovaLife 2 GX+; Pouchkins; Premier;Restore;Securi-T USA Hollister (SP) - Conform 2; First Choice; HOLLISTER UROSTOMY BAGS; Impression - C; Karaya 5; Moderma Flex Hollister (SP) - HOLLISTER STOMA BAGS; Hollister Wound Drainage Collectors; STOMA BAGS;Center Point Lock; Compact; Hollister (LN,LS,SP) - A BAGS; HOLLISTER DRAINING WO; HOLLISTER DRAINING WOUND MANAGEMENT Hollister (SP) - Holligard; Hollister; Hollister Solo Stoma Cap; Invent; Karaya 5; m9; Moderma Flex; New Image; Hollister (SP) - Tandem; Urostomy Drain Tube Adapter; Loop Ostomy Bridge; A BAGS; HOLLISTER DRAINING WO; HOLLISTER DRAI Zimmer (LN,LS) - StageOne shoulder Cement Spacer Molds ETS_Wound (LS) - Mirragen Advanced Wound Matrix; MirraSurg SMC_Somerset (LS) - Steripath Flow Blood Collection System Carefusion (EP1,SN,LS,NT) - Alaris Safety Male Luer Carefusion (EP1,SN,LS,NT) - PrimeSaver Sets (Ball Valve) Lifenet2559 (CH1,WH,LSRTC) - PliaFX Flo Sanuwave (LN,LS,SN) - UltraMIST KeySugical6941 (LSRTC) - Electro Lube NXT Zimmer (LN,LS) - CRUCIATE LIGAMENT BUTTON Zimmer (LN,LS) - Maxfire BVI1689 (EP1) - Irrigating Cystotome DJO3655 (NT,LS,LN) - Adaptable, Leg Positioner Disposable Kit DJO3655 (NT,LS) - Adaptable Arm Positioner Disposable Kit DJO3655 (NT,LS,LN) - Adaptable, Knee Positioner Disposable Kit DJO3655 (NT,LS,LN) - Adaptable, UE Disposable Kit DJO3655 (NT,LS) - Adaptable Retractor Holder Sleeve, 5PK KeySurgical6941 (LS) - Vascular Loops Syntech7829 (NT) - The Ahn Tray/ Ahn Tray Zimmer (LN,LS) - Comprehensive Reverse Shoulder - HA Glenosphere Baseplates Zimmer (LN,LS) - Single/multiple component metallic bone fixation appliances Zimmer (LN,LS) - G7 Dual Mobility System StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK-SOFT TISSUE FIXATION StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK BONE-TENDON-BONE BVI1689 (EP1) - CustomEyes Zimmer (LN,LS) - Toggleloc Zimmer (LN,LS) - Maxfire Acuderm1463 (WH,LS) -Acu-Punch Kit BVI1689 (EP1) - Atomic Edge Knife BVI1689 (EP1,CH1) - Beaver Micro-Sharp® Blade BVI1689 (EP1) - Beaver Xstar Knives BVI1689 (EP1) - Beaver Micro-Unitome Knife BVI1689 (EP1) - Beaver Sideport MVR Knife BVI1689 (EP1) - Beaver Optimum Knife BVI1689 (EP1, CH1)- Beaver Micro-Sharp® Blade BVI1689 (EP1) - Beaver Swivel Fixation Ring 13mm BVI1689 (EP1) - Beaver Xstar Safety Slit Knife BVI1689 (EP1) - CustomEyes BVI1689 (EP1) - Viscoflow Cannula Biomeric6631 (LN) - TrabEx BVI1689 (EP1) - Beaver Xstar Slit Knife Hollister (LN,LS) - Hollister Suction Tube Attachment Device SMC_Amery (LS) - Steripath Micro Blood Collection System Molded Products4803 (LS) - Sterile Tube Occluding Forceps Zimmer (LN, LS) - BIOMET PHOENIX ANKLE NAIL SYSTEM Zimmer (LN, LS) - Phoenix Ankle Nail System Biomet3824 (LS) - Titanium Hexed Screw StrykerInstruments (LS) - iVAS 8 GAUGE HAND DRILL StrykerInstruments (LS) - iVAS 8 Gauge Access Cannula StrykerInstruments (LS) - 10 Gauge Hand Drill Sterile StrykerInstruments (LS) - iVAS 8G Bevel Stylet Merit1383 (SN) - ShortStop Temporary Sharps Holder Merit1383 (TM) - BackStop Plus Closed Waste Basin Merit1383 (SN) - ShortStop Advantage Temporary Sharps Holder Merit1383 (NT,SN) - ShortStop Advantage Temporary Sharps Holder Ranfac3098 (NR) - SS-1529, Hypodermic Needle, S-115 BVI1689 (CH1,EP1) - Retrobulbar BVI1689 (EP1, CH1) - Peribulbar Clearside6394 (MN,SP) - SCS Microinjector Depuy (NR) - CELLECT BONE MARRO; CONFIDENCE SPINAL CEMENT SYSTEM PDI2826 (CH1) - Hygea Sterile Saline Wipe Atricure2121 (GR,LN*,LS*) - cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L) Atricure2121 (GR,LN*,LS*) - cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX) Atricure2121 (GR,LN*,LS*) - cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) Atricure2121 (GR,LN*,LS*) - cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) Zimmer (LN,LS) - COMPREHENSIVE CONVERTIBLE GLENOID TigerAesthetics14268 (SN,LS-RTC) - Magnetic Pro Locator Zimmer (LN,LS) - TILOW PROFILE SCREWS for MODULAR PROTUSIO CUP Accumedix377 (LS) - Blue Sky Bio Dental Implant System - Internal Octagon Taper; Blue Sky Bio Dental Implant System Atricure2121 (GR,LN*,LS*) - EPi-Ease Epicardial Access Device (EAS) Mentor35289 (LS) - External Fixation System StrykerPR3324 (GR, LS, VG) - Krackow Press. Merit1383 (SN,NT) - PAL - Pen and Labels KeySurgica6941 (LS) - Sterile Labels RMAC1276 (WT) - PharmaTags Zimmer (LN, LS) - BIOMET FEMORAL LOCKING NAIL SYSTEM Zimmer (LN, LS) - Phoenix Ankle Nail System Zimmer (LN, LS) - Phoenix Retrograde Nail System Zimmer Biomet (LS) - HydroDam Cannula System Zimmer (LS) - HydroDam Cannula System Zimmer (LN,LS) - MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKIN Zimmer (LN,LS) - ZIMMER BIOMET TYPE1 COCR HEADS Zimmer (LN,LS) - COCR MODULAR HEADS - PRIMARY MedGyn1533 (LS) - Curette Rigid Straight 9mm Zimmer (LN, LS) - Trauma Fixation Systems Zimmer (LN, LS) - Nail Extractor Tap, Trauma Fixation Systems Zimmer (LN,LS) - Maxfire Zimmer (LN,LS) - Biomet Headless Compression And Twist-Off Screws StrykerPR3324 (GR, LS, VG) - STRYKER AHTO TUBE SET PACKAGING Stryker3324 (GR, LS, VG) - STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING StrykerPR3324 (GR, LS, VG) - STRYKER AHTO TUBE SET WITH TIP PACKAGING StrykerPR3324 (GR, LS, VG) - Ahto Cassette Tube Set StrykerPR3324 (GR, LS, VG) - Ahto Cassette Tube Set with tip StrykerPR3324 (GR, LS, VG) - Ahto Cassette Tube Set With Y Connector StrykerPR3324 (GR, LS, VG) - Ahto Dual Spike Cassette Tube Set Zimmer (LN,LS) - COMPREHENSIVE REVERSE SHOULDER SCREWS Zimmer (LN,LS) - Comprehensive® Reverse Shoulder Accumedix3772 (LS) - Blue Sky Bio Dental Implant System - Internal Hex; Blue Sky Bio Dental Implant System - Tri-Lobe Hollister (LN, LS) - Horizontal Tube Attachment Device (H-TAD) Hollister (LN, LS) - Hollister Horizontal Tube Attachment Device Zimmer (LS) - appliance, fixation, nail/blade/plate combination, multiple component22 RSITech (LSRTC) - ProteX Zimmer (LN,LS) - Ziptight Zimmer (LN,LS) - Toggleloc Zimmer (LN,LS) - Titanium Interference Screws Merit1383 (TM) - Finale Radial Compression System DVL-Op6436 (TM) - BRCDXL-05 Breast Reduction Compression Device XL DVL-Op6436 (TM) - BRCD-05 Breast Reduction Compression Device Merit1383 (TM) - RADstat Radial Artery Compression Device PrecisionMedical (NR) - T-RING Zimmer (LN,LS) - HFN 125 DEGREE 9-13 MM, 180MM Zimmer (LN,LS) - HFN 130 DEGREE 9-13 MM Zimmer (LN,LS) - HFN RH 125 DEGREE 9-13MM Zimmer (LN, LS) - COMPREHENSIVE FRACTURE SLEEVE Zimmer (LN,LS) - BIOMET PHOENIX ANKLE NAIL SYSTEM Zimmer (LN, LS) - Phoenix Ankle Nail System Zimmer (LN,LS) - TRAUMA INTERNAL FIXATION SYSTEMS Zimmer (LN,LS) - DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE Atricure2121 (GR, LN,* LS*) - AtriCure - AtriClip LAA Exclusion System Atricure2121 (GR, LN,* LS*) - AtriClip LAA Exclusion System Atricure2121 (GR, LN,* LS*) - Atricure - Gillinov-Cosgrove Selection Guide Eagle1350 (NT,SN) - Tomcat Cervical Spinal System Zimmer (LN,LS) - Prosthesis, Elbow, Constrained, Cemented Zimmer (LN, LS) - MODIFIED DISTAL RADIUS PLATING SYSTEM HOLLISTER (LN, LS) - Drain Tube Attachment Device (D-TAD) HOLLISTER (LN, LS) - D-TAD; Hollister Drain Tube Attachment Device Zimmer (LN,LS) - Toggleloc Anodyne3068 (LN, LS) - PEYMAN BVI1689 (EP1) - Soft Tip Cannula BVI1689 (EP1) - LASIK Irrigating Cannula BVI1689 (EP1) - Flexible Tip Cannula BVI1689 (EP1) - Visitec Nucleus Hydrodissector BVI1689 (EP1) - Micro J Shape Cannula BVI1689 (EP1) - Irrigating Cystotome BVI1689 (EP1) - Anterior Chamber Cannula [Rycroft] BVI1689 (EP1) - Viscoflow Cannula BVI1689 (EP1) - Cortical Cleaving Hydrodissector BVI1689 (EP1) - Infusion Cannulas BVI1689 (EP1) - Lacrimal Cannula SonomedEscalon8890 (MN) - Viscous Fluid Cannula Eagle1350 (NT,SN) - Blackhawk Cervical Spacer System Medivis37554 (LSRTC) - Spine Navigation System Zimmer (LN,LS) - 2.7X26MM CORT LOCK SCR ST Zimmer (LN,LS) - 2.7X28MM CORT LOCK SCR ST Zimmer (LN,LS) - 2.7X14MM CORT LOCK SCR ST Zimmer (LN,LS) - 2.7X30MM CORT LOCK SCR ST Zimmer (LN,LS) - 2.7X24MM CORT LOCK SCR ST Zimmer (LN,LS) - 2.7X20MM CORT LOCK SCR ST Zimmer (LN,LS) - 2.7X12MM CORT LOCK SCR ST Zimmer (LN,LS) - 2.7X10MM CORT LOCK SCR ST Zimmer (LN,LS) - 2.7X16MM CORT LOCK SCR ST Zimmer (LN,LS) - 2.7X18MM CORT LOCK SCR ST Zimmer (LN,LS) - 2.7X22MM CORT LOCK SCR ST ZimmerBiomet (LN,LS) - POLYAX Zimmer (LN,LS) - VERSA-DIAL HUMERAL HEAD PROSTHESIS Zimmer (LN,LS) - Comprehensive Shoulder System Zimmer (LN,LS) - COMPREHENSIVE ANATOMIC VERSA D Neilmed6807 (NT ) - NeilMed NasaMist Isotonic Saline Spay 177 mL Neilmed6807 (NT,SN*) - CVS SALINE NSL MST Neilmed6807 (NT,SN*) - Nasamist Saline Spray Full Stream, Gentle Stream and Medium Stream Neilmed6807(NT,SN*) - Nasamist Hypertonic Spray 125ml Neilmed6807 (NT,SN*) - PediaMist Neilmed6807 (NT,SN*) - Nasamist Saline Spray Pediatric Neilmed6807 (NT,SN*) - NasaMist Neilmed6807 (NT,SN*) - Caring Mill Saline Spray 125 mL Neilmed6807 (NT,SN*) - CVS Saline Nasal Mist Neilmed6807 (NT,SN*) - Target Nasal Spray Neilmed6807 (NT ) - NeilMed Naspira Drops Neilmed6807 (NT ) - NeilMed NasaMist Isotonic Saline Spay 75 mL Neilmed6807 (NT,SN*) - NeilMed Nasamist Hypertonic Saline Spray Neilmed6807 (NT,SN*) - Life Brand Sterile Saline Nasal Mist Neilmed6807 (NT,SN*) - Himalays Chandra - Neti Spray (Sterile Saline Spray) Neilmed6807 (NT,SN*) - Himalays Chandra - Neti Spray (Extra Strength Sterile Saline Spray) Neilmed6807 (NT ) - NeilMed NasaMist Isotonic Saline Spay 125 mL Neilmed6807 (NT,SN*) - Nasamist All-in-one Saline Spray Zimmer (LN,LS) - Modular Hybrid Glenoid Zimmer (LN,LS) - Comprehensive Shoulder System Acuderm1463 (WH,LS) - Acu-Punch Neilmed6807 (NT,SN*) - NasaMist - Isotonic Neilmed6807 (NT) - NeilMed NasaMist Extra Strength (Hypertonic) Saline Spray Neilmed6807 (NT,SN*) - Ultra Gentle Spray Neilmed6807 (NT,SN*) - Walgreen Nasal Mist Neilmed6807 (NT) - Walgreens Nasal Mist Neilmed6807 (NT) - NeilMed SinuHale Zimmer (LN,LS) - SALVAGE ONCOLOGY HIP AND TOTAL FEMUR SYSTEM Zimmer (LN,LS) - ZIMMER BIOMET TYPE1 COCR HEADS Zimmer (LN,LS) - COCR MODULAR HEADS - PRIMARY Zimmer (LN, LS) - BIOOMET TIBIAL LOCKING NAIL SYSTEM Zimmer (LN, LS) - Phoenix Nail System Zimmer (LN,LS) - Versanail Zimmer (LN,LS) - DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE Acumed4864 (LSRTC) - BioBridge Acumed4864 (LSRTC) - BioBridge Resorbable Chest Wall Stabilization Plate Zimmer (LN,LS) - Toggleloc Zimmer (LN,LS) - Single/multiple component metallic bone fixation appliances and accessories MolderProducts4803 (LS) - Injection luer caps / plugs MolderProducts4803 (LS) - Lure Lock Cap Merit1383 (SN,NT) - Futura Safety Scalpel BVI1689 (EP1) - Beaver Sclerotome Blade BVI1689 (EP1) - Beaver Mini-Blades BVI1689 (EP1) - Beaver Pocket Blade BVI1689 (EP1) - BeaverGuard Blade OmegaSurgical (LSRTC) - BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Zimmer (LN) - blade, saw, general and plastic surgery, surgical StrykerPR3324 (GR, LS, VG) - PKG ,ENT IRR.AGG.SHAVER BLADE StrykerPR3324 (GR, LS, VG) - SJ Cutter Mnscs StrykerPR3324 (GR, LS, VG) - Cutter Meniscus StrykerPR3324 (GR) - 4 mm ENT MicroDebrider AGGRESSIVE SERRATED StrykerPR3324 (GR, LS, VG) - Cutter Full Radius StrykerPR3324 (GR, LS, VG) - Bur TMJ 2mm StrykerPR3324 (GR, LS, VG) - Bur TMJ 3mm StrykerPR3324 (GR, LS, VG) - SJ Cutter StrykerPR3324 (GR, LS) - 4mm Aggressive Serrated StrykerPR3324 (GR, LS, VG) - SHARPEDGE SHAVER BLADE 4MM StrykerPR3324 (VG) - Full Radius Cutter, Arthroscopic Shaver Blade StrykerPR3324 (VG) - Hooded Abrasion Bur, Arthroscopic Shaver Blade StrykerPR3324 (VG) - Aggressive Cutter, Arthroscopic Shaver Blade OrchidUnique5936 (LN) - Blade, Saw, General & Plastic Surgery, Surgical - Signature Series UltraLite Carefusion (LS,NT) - Gravity Burette Sets Zimmer (LN,LS) - Comprehensive Shoulder System Zimmer (LN,LS) - COMPREHENSIVE FRACTURE SLEEVE QTS3938 (LS) - Thread Implant Zimmer (LN,LS) - Toggleloc Zimmer (LN,LS) - BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR Zimmer (LN,LS) - Juggerknot Zimmer (LN,LS) - Versanail Depuy (LN,LS) - Focus (hip), Articul/eze Zimmer (LN) - Comprehensive Shoulder System Accumedix3772 (LS) - Blue Sky Bio Anodyne3068 (LN, LS) - SIMCOLE LENS LOOP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMF Syringe, Piston General Hospital Class 2 880.5860 2017-01-03
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2012-12-27
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-08-10
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-08-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-04-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-04-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-01-02
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-02
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2024-07-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-02-02
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2015-02-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-02-02
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2026-06-03
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2020-06-16
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2020-06-16
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-06-16
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2020-06-16
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2020-06-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-06-16
PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Orthopedic Class 2 888.3310 2020-06-16
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2020-06-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-02
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-08-21
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2020-08-21
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-12-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-07-29
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-07-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-09-13
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2020-01-31
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-01-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-12-17
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-12-17
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2012-12-27
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2012-12-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-08
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 2012-12-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-11-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-07-29
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-07-29
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2019-10-30
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2019-10-30
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2022-03-24
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2022-03-24
MON System, Hemodialysis, Remote Accessories Gastroenterology, Urology Class 1 876.5820 2024-03-11
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2013-01-17
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2021-05-24
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2021-05-24
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2021-05-24
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-05-24
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2021-05-24
PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Orthopedic Class 2 888.3310 2021-05-24
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2021-05-24
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-05-24
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-05-24
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2021-05-24
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-05-24
OLR Oral Wound Dressing Unknown Class U N/A 2012-12-19
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2023-08-15
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2023-08-15
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2023-08-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-05-08
FID Tubing, Dialysate Gastroenterology, Urology Class 2 876.5820 2020-11-13
OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus General, Plastic Surgery Class 2 878.4683 2025-12-15
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2012-12-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-19
HWB Extractor Orthopedic Class 1 888.4540 2013-01-07
FID Tubing, Dialysate Gastroenterology, Urology Class 2 876.5820 2020-11-13
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-09-11
HDY Dilator, Cervical, Hygroscopic-Laminaria Obstetrics/Gynecology Class 2 884.4260 2020-03-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-08
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2022-06-30
PZX Left Atrial Appendage Clip, Implantable General, Plastic Surgery Class 2 878.4300 2025-01-23
ELZ Crown, Preformed Dental Class 1 872.3330 2019-11-20
LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery Class 3 878.4490 2012-12-28
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2026-05-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-10-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-02
GXH Device, Surgical, Cryogenic Neurology Class 2 882.4250 2023-01-11
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2026-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-16
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2024-10-31
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2018-10-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-07
OKS Lacrimal Stents And Intubation Sets Unknown Class U N/A 2020-01-23
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2023-03-29
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2023-03-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-03-29
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-01-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-02
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-09-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-08
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2012-11-15
OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus General, Plastic Surgery Class 2 878.4683 2023-02-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-11-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-11-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-11-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-02-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-02-06
SCL Allergen And Vaccine Delivery Needles General Hospital Class 2 880.5570 2018-02-15
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2015-12-07
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2015-02-02
PZX Left Atrial Appendage Clip, Implantable General, Plastic Surgery Class 2 878.4300 2024-09-18
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-09-18
FQH Lavage, Jet General Hospital Class 2 880.5475 2012-12-27
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2012-12-27
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-02
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2025-01-02
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-01-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-01-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2018-01-22
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-01-22
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2018-01-22
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2012-12-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-11-30
KJF System, Suspension, Cell Culture Hematology Class 1 864.2240 2013-12-18
MAB Marker, Cardiopulmonary Bypass (Vein Marker) Cardiovascular Class 2 870.3450 2025-06-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-11-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-10-16
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2018-10-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-10-16
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2018-10-16
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-01-03
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-11-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-12-17
NQR Sealant, Dural Unknown Class 3 N/A 2024-01-26
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2012-11-16
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-02-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-11-30
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2012-12-27
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Orthopedic Class 2 888.3800 2023-01-05
LZP Aid, Surgical, Viscoelastic Ophthalmic Class 3 886.4275 2013-12-18
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2012-10-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-08
FRO Dressing, Wound, Drug Unknown Class U N/A 2018-09-18
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-09-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-02
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2003-05-01
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-12-18
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2012-12-27
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2012-12-19
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2022-01-07
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-01-07
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2022-01-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2014-11-06
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2024-12-17
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-12-27
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-07-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-03-26
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-07-29
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-07-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-11-20
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2012-11-07
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2020-11-13
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2012-12-27
OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus General, Plastic Surgery Class 2 878.4683 2023-02-10
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2012-12-28
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2013-09-13
ITG Bandage, Cast Physical Medicine Class 1 890.3025 1994-04-11
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-12-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-12-22
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2024-12-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-12-02
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2018-02-05
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2013-01-17
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-01-30
QKL Lipoaspirate Washing System For Aesthetic Body Contouring General, Plastic Surgery Class 2 878.5040 2024-09-16
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2023-08-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-08-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-09-11
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2024-12-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-02-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-02-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-11-08
PST Aortic Annuloplasty Ring Cardiovascular Class 2 870.3800 2018-05-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-11-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-02-02
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2024-12-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-02
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-01-25
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-09-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-02
HXQ Crimper, Pin Orthopedic Class 1 888.4540 2023-03-29
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-04-30
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2015-04-30
GDS Bag, Stomal Gastroenterology, Urology Class 1 876.5900 2012-12-27
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2023-08-15
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-08-15
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-08-15
QSZ Absorbable Synthetic Wound Dressing Unknown Class U N/A 2018-02-09
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2025-11-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-20
LZP Aid, Surgical, Viscoelastic Ophthalmic Class 3 886.4275 2012-12-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-09-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-12-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2026-04-22
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2026-04-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-10-16
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2024-12-17
FQM Bandage, Elastic General Hospital Class 1 880.5075 1994-04-11
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2021-02-25
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2019-09-27
NRB Wound Cleaner, Ultrasound General, Plastic Surgery Class 2 878.4410 2014-11-04
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-11-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-09-16
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2013-01-04
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-12-17
HNY Cystotome Ophthalmic Class 1 886.4350 2012-12-27
BTX Board, Arm (With Cover), Sterile General, Plastic Surgery Class 1 878.3910 2023-01-24
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2013-01-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-02-06
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-04-22
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2020-09-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-12-18
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2024-12-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-02
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-04-24
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-04-24
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2021-04-24
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-04-24
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-12-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-08-21
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2012-12-28
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2025-04-16
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-27
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2020-02-06
NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Orthopedic Class 2 888.3535 2020-02-06
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-02-14
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2024-12-17
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-06-23
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-06-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-03-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-11-30
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2020-11-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-04
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2019-09-27
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2018-05-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-12-14
HRX Arthroscope Orthopedic Class 2 888.1100 2012-12-18
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2012-12-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-03-29
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-03-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-02
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2026-04-06
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2012-11-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-12-17
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-11-20
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2012-12-28
IPM Cover, Limb Physical Medicine Class 1 890.3025 2025-04-16
GXH Device, Surgical, Cryogenic Neurology Class 2 882.4250 2024-09-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-02
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-01-02
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2021-08-10
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-08-10
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-08-10
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-08-10
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2021-08-10
MJI Specimen/Tissue, Identification Orientation Pathology Class 1 864.3010 2012-12-27
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-02-05
LCJ Tissue Expander And Accessories Unknown Class U N/A 2024-03-14
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-06-23
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2012-11-08
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2012-11-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-12-17
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-07-29
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-09-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-08
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-08
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-11-20
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2020-02-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-02-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2020-02-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2020-02-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-02-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-12-17
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2012-12-18
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2012-11-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-04
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-12-27
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-08-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-02
HHI System, Abortion, Vacuum Obstetrics/Gynecology Class 2 884.5070 2020-03-12
HWX Tap, Bone Orthopedic Class 1 888.4540 2018-01-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-06-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-07
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2014-04-08
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2012-11-07
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2012-12-18
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2012-12-18
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2012-12-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-08
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-08-21
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2020-08-21
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2020-08-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-07-29
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2015-07-16
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2022-05-27
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2022-05-27
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2018-12-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-19
PUD Labware, Assisted Reproduction, Exempt Obstetrics/Gynecology Class 2 884.6160 2024-03-26
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-11-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-11-16
HXX Screwdriver Orthopedic Class 1 888.4540 2020-03-19
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2012-11-07
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2024-12-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-12-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-01-29
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-03-24
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-03-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-12-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-11-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-04
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-12-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-12-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-09-08
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2021-09-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-09-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-09-08
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2021-09-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-09-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-08
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2020-02-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-12-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-01-17
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-09-18
PZX Left Atrial Appendage Clip, Implantable General, Plastic Surgery Class 2 878.4300 2024-09-18
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-12-05
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-08-03
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-08-03
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2021-08-03
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2021-08-03
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-27
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2012-11-07
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2012-11-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-03-05
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2012-12-18
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2017-01-03
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2012-11-15
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2012-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-04
GCE Adaptor, Catheter General, Plastic Surgery Class 1 878.4200 2024-01-29
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-27
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-19
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2012-12-19
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-12-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-03-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-03-07
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-01-03
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-03
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2013-01-03
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-01-03
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-10-31
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-02
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2014-04-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-04
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-01-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-09-11
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2024-12-17
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 2023-07-25
KCO Nasal Spray, Ent Delivery Ear, Nose, Throat Class 1 874.5220 2021-12-02
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2024-12-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-06-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-12-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-12-19
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2013-01-17
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-01-07
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-01-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-05-02
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-01-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-02
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2012-11-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-04
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-12-17
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2012-12-19
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2014-02-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-01-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-10-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-11-21
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2024-12-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-08
DGR Whole Human Serum, Antigen, Antiserum, Control Immunology Class 1 866.5700 2023-02-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-19
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-03-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-03-12
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2025-04-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-02
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-01-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-02
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-11-16
PST Aortic Annuloplasty Ring Cardiovascular Class 2 870.3800 2018-05-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-01-31
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2020-09-15
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2025-03-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-11-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-09
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2012-12-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-11-20
MKY System, Skin Closure General, Plastic Surgery Class 1 878.4320 2012-12-27
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2013-01-07
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2013-01-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-02
LYQ Accessories, Fixation, Spinal Intervertebral Body Orthopedic Class 1 888.4540 2024-12-30
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2020-03-13
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-01-03
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-03
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2019-12-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-02
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-02
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-03-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-02
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-05-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-02-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-05-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-11-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-11-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-03
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-04
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-10-27
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2018-02-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-01-17
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2012-11-07
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2020-01-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-11-20
FRO Dressing, Wound, Drug Unknown Class U N/A 2020-11-12
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2024-12-18
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2015-12-21
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2013-01-04
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-01-04
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-01-04
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-04
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2012-12-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-07-29
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-07-29
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-01-03
NQR Sealant, Dural Unknown Class 3 N/A 2024-01-26
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018811167 MEDIVATORS INC Rogers, MN, US
3038285067 Synergy Sterilisation Kulim (M) Sdn. Bhd Seberang Perai Selatan Pulau Pinang, MY
3031571464 Herotron E-Beam Service GmbH Bitterfeld Saxony-Anhalt, DE
3010897183 Synergy Health Marseille SAS CHUSCLAN Gard, FR
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28
K141345 Tornier S.A.S. AEQUALIS FX2 2014-11-18
K040336 Synthes (Usa) SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM 2004-04-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number Establishment Name Location
3027338968 RONCADELLE OPERATIONS SRL Castel Mella Brescia, IT
3029328631 PEGASUS IMPORTS Houston, TX, US
3021067373 VVT MED Ltd Kfar Saba Central, IL
3009249481 JMS Co.,Ltd. Miyoshi Plant Miyoshi Hiroshima, JP
1416980 BAXTER HEALTHCARE CORPORATION ROUND LAKE, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1424263. Last updated year: 2026. Please use registration number 1424263 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.